Medtech Color recently announced the top 10 finalists for its 2022 Pitch Competition. The Medtech Color 2022 Pitch Competition is a foundational start for medical technology, early-stage startups creating innovative technologies. It focuses on startups led by Black and Brown founders to showcase products and services that directly benefit patients. Get the full story on […]
Dialysis
Outset Medical rises on Street-beating Q4 revenues, high growth projections for 2022
Outset Medical (NASDAQ:OM) shares shot up today on fourth-quarter revenues that beat the consensus forecast. OM shares were up more than 16% at $39.77 per share by late afternoon trading today. MassDevice’s MedTech 100 Index, which includes stocks of the world’s largest medical device companies, was down 1.6%. The San Jose, California-based dialysis technology developer posted […]
FDA clears CloudCath peritoneal dialysis at-home patient monitor
CloudCath today announced that it received FDA 510(k) clearance for its CloudCath remote monitoring system for peritoneal dialysis patients. San Francisco-based CloudCath designed the monitoring system as a data-driven, cloud-based, remote monitoring platform for at-home monitoring of peritoneal dialysis. It uses continuous analytics with its technology to integrate seamlessly into a patient’s daily PD protocol, […]
NextKidney buys Dialyss to support its home hemodialysis system
NextKidney recently announced that it has acquired Dialyss to boost the development of its portable Neokidney hemodialysis device. The financial terms of the deal were not disclosed. Singapore-based Dialyss specializes in technologies for the sorbent-based regeneration of dialysate during home dialysis. “Joining forces with Dialyss Pte Ltd will bring Neokidney BV in the best position […]
Hugo, renal denervation and diabetes businesses to drive growth despite setbacks, Medtronic CEO says
Although three major pipelines at Medtronic (NYSE:MDT) have hit recent speed bumps, CEO Geoff Martha reiterated his belief that they will be significant growth drivers. Speaking at the 40th Annual J.P. Morgan Healthcare Conference today, Martha expressed his disappointment with the hitches in important businesses. “I feel a mix of disappointment and anger,” Martha said. […]
FDA grants breakthrough nod to Fist Assist Devices’ vein dilation system
Fist Assist Devices announced today that it received FDA breakthrough device designation for the Fist Assist model FA-1 device. Las Vegas-based Fist Assist touts its FA-1 device as the world’s first wearable for pre-surgical vein dilation that promotes AV fistula creation in adult patients diagnosed with chronic renal failure whose pre-operative assessment of the venous […]
FDA clearance enables Outset Medical to streamline manufacturing
Outset Medical (NSDQ:OM) announced that a new sterilization method for its Tablo hemodialysis system received FDA 510(k) clearance. San Jose, California-based Outset’s new sterilization method for the cartridge — utilized in the Tablo system — enables the company to start cartridge production through a manufacturing partner in Mexico. The move facilitates the localization of cartridge […]
RenalSense raises $14M to boost commercialization, expand product portfolio
RenalSense announced today that it raised $14 million to increase global commercialization efforts and advance its next-generation products. Jerusalem-based RenalSense develops the FDA-cleared and CE-marked Clarity RMS critical care monitoring system for the early detection of changes in renal function and acute kidney injury (AKI) risk, along with treatment monitoring. Clarity RMS has been installed […]
Baxter says its digital health platform for dialysis improves survival, reduces hospitalizations
Baxter (NYSE:BAX) today touted new data demonstrating survival rate improvements with its Sharesource digital health platform. Deerfield, Illinois–based Baxter presented data during the American Society of Nephrology’s annual Kidney Week that took place last week, according to a news release. Baxter designed its Sharesource remote patient management digital health platform for use in helping to […]
Outset Medical achieves landmark Medicare approval for home dialysis system
Outset Medical (NSDQ:OM) announced today that it received CMS approval for a payment adjustment on its Tablo hemodialysis system. San Jose, California-based Outset said in a news release that it received the first-ever CMS approval for a Transitional Add-on Payment Adjustment for New and Innovative Equipment and Supplies (TPNIES). The decision helps encourage healthcare providers […]
Baxter warns on some PrisMax hemodialysis machines
Baxter (NYSE:BAX) issued a device correction in Europe for its PrisMax hemodialysis machine due to a software anomaly. The correction relates to a software anomaly occurring during use. If the operator initiates therapy with a saved prescription profile and makes a change to the prescription after a disposable filter change using the “Same Patient” button, […]